Free website hits

An independent, credible, science-led Food and Drug Administration has long been vital to America’s public, social, and economic health. It is even more essential today.

As our country seeks to work its way out of a catastrophic pandemic and turn the page on one of the worst presidential administrations in its history — including one that bullied and traumatized FDA leaders and officials — President Joe Biden and his administration must choose the FDA’s next leader with care and caution.

The FDA needs a leader who will decisively move on from the political weakness too often shown by Commissioner Stephen Hahn. The FDA needs a leader experienced in the public health sphere and with management experience at the very top of it. The FDA also needs new blood in its leadership.

advertisement

We believe that Biden has a clear choice who meets all of these criteria: Joshua Sharfstein of Johns Hopkins University. Sharfstein, a physician, is a former principal deputy commissioner of the FDA from the Obama Administration who served with distinction under former commissioner Margaret Hamburg. He has been a champion of greater transparency at FDA and a defender of its core mission against those who would use an anachronistically-construed and weaponized First Amendment to weaken the agency.

Full disclosure: We are not friends of Sharfstein, though we have interacted with him on panels here and there. He did not ask us to write this essay, and has no idea we are writing it.

advertisement

He has argued, along with Hamburg, for thinking about the FDA as a public health agency, one that has broad responsibilities and many stakeholders. And he has already worked to coordinate and harmonize operations between the FDA and the Centers for Medicare and Medicaid Services, which is an important priority of the Biden Administration. Finally, he has supported and advanced FDA modernization in areas of methodologies, therapeutics, and procedures.

Sharfstein is also a distinguished academic and public servant in the public health realm. Before he began working at the FDA in 2009, he had worked in Congress and had served as public health commissioner of Baltimore. After his service at the FDA he served as Secretary of Health and Mental Hygiene in Maryland.

He is deeply knowledgeable about the public health needs of minority populations that have been so ravaged by Covid-19, including the kinds of peoples he served in Maryland and in Baltimore. And at a time when the FDA commissioner needs to be attentive to a range of audiences in Congress, the scientific community, the American people, and the biopharma industry, Sharfstein’s record of diverse service in national, state and local government positions him well to respond to the agency’s challenges.

His emphasis on scientific rigor and procedural consistency is exactly what the global biopharmaceutical industry needs at a time of mistrust and uncertainty. We all witnessed the damage done to the FDA’s reputation by the debacle of Hahn’s poor decision-making on hydroxychloroquine and his hagiographic endorsement of convalescent plasma last summer. In the weeks that followed, a troubling public health development ensued as millions of Americans decided that any vaccine approved by an FDA that would bow to the will of a presidential candidate would not be a treatment they would take.

A loss of confidence in the FDA leads to treatments that are not deemed credible or reliable by patients, clinicians, and payers. And that means billions of dollars lost for biopharmaceutical companies.

The destructive legacies of procedural irregularities aren’t confined to vaccines. Another example of weakened legitimacy for FDA-approved treatments came in the FDA’s approval of eteplirsen (Exondys, made by Sarepta Therapeutics) for Duchenne’s muscular dystrophy. The clinical trial evidence for eteplirsen was weak, and perhaps the best that could have been said for the drug at the time was that it appeared to induce a rise in observed dystrophin levels. The hoped for clinical benefit for people with Duchenne’s never materialized in clinical studies, however. The FDA’s advisory committee voted against it and the relevant review division chief recommended against approval, only to be overruled by Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research.

The procedural irregularity of the FDA’s decision was met with a silent but massive rebuke by the American health care system. In the years that followed eteplirsen’s approval, American insurers systematically declined to pay for it, Anthem stated publicly that the clinical benefit from Exondys 51 “has not been demonstrated,” while a representative of the insurance industry soberly told The New York Times that “There’s more about this drug that we don’t know than we do know. And that’s where payers are really struggling.”

When the FDA has declared something safe and effective and informed observers refuse to pay for it and further say that they don’t know whether it works, the FDA has failed. It’s the same kind of falloff in confidence we witnessed when, after the convalescent plasma debacle of summer 2020, the willingness of Americans to get a Sars-Cov2 vaccine fell by 10 percentage points or more.

The sad saga of eteplirsen is important not only because it shows the social value of a robust and independent FDA, but because it appears that Woodcock is another potential candidate for FDA commissioner. We respect Woodcock for her service, but we also believe that the FDA needs new, fresh perspectives and leadership.

Beyond eteplirsen, several instances of Woodcock’s past leadership should also give the Biden administration cause for concern. One is the role she apparently played in delaying the authorization for the levonorgestrel-containing emergency contraceptive (“Plan B”) during the George W. Bush administration, in which she warned about access to the drug leading to extreme promiscuity among adolescents. The science has since proved that stance wrong.

Woodcock’s service as a civil servant is distinguished, but the post of FDA commissioner calls for a different set of skills, and someone who can withstand the political pressures that face the agency even during ordinary times.

As a weary and uncertain America faces the likelihood of needing continual rollout of new coronavirus treatments in the years to come, the stakes for President Biden’s choice for FDA leadership could not be higher. A public health leader with top-level FDA experience, a distinguished service record in state and local government, and a commitment for procedural integrity is available in Dr. Joshua Sharfstein.

We hope that the president will make the wise and courageous choice to appoint him as America’s next FDA commissioner.

Daniel Carpenter is professor of government at Harvard University and author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA” (Princeton University Press, 2010). Gregg Gonsalves is an assistant professor at the Yale School of Public Health, an associate professor (adjunct) at the Yale Law School, and a 2018 MacArthur Fellow.

Source: STATNEWS.COM

Leave a Reply

ArabicChinese (Simplified)EnglishFrenchGermanItalianJapanesePortugueseRussianSpanish

[mc4wp_form id="449"]